País: Reino Unido
Língua: inglês
Origem: VMD (Veterinary Medicines Directorate)
Moxidectin
Chanelle Pharmaceuticals Manufacturing Ltd
QP54AB02
Moxidectin
Oral solution
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Sheep
Endectocide
Authorized
2018-05-14
Unlimited renewal: August 2022 AN: 01156/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Moxidectin Oral (Chanelle) 1 mg/ml oral solution for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Moxidectin 1.00 mg EXCIPIENT: Benzyl Alcohol (E1519) 40.0 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral solution Clear colourless to yellowish solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of mixed infections of sheep with parasites sensitive to moxidectin Adult and/or immature gastro-intestinal nematodes: - _Haemonchus contortus _(including inhibited larvae) - _Teladorsagia circumcincta _(including inhibited larvae) - _Teladorsagia trifurcata_ - _Trichostrongylus axei _(including inhibited larvae) - _Trichostrongylus colubriformis_ - _Trichostrongylus vitrinus_ - _Nematodirus battus_ - _Nematodirus spathiger_ Unlimited renewal: August 2022 AN: 01156/2022 Page 2 of 8 - _Nematodirus filicolis _(adults only) - _Strongyloides papillosus _(larval stages only) - _Cooperia curticei _(adults only) - _Cooperia oncophora_ - _Oesophagostomum columbianum_ - _Oesophagostomum venulosum _(adults only) - _Chabertia ovina_ - _Trichuris ovis _(adults only) Adult respiratory tract nematode: - _Dictyocaulus filaria_ The product has a persistent effect in preventing reinfection: for 5 weeks by _Teladorsagia circumcincta _and _Haemonchus contortus_ for 4 weeks by _Oesophagostomum columbianum_ Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of: _Haemonchus contortus_ _Teladorsagia circumcincta_ _Trichostrongylus colubriformis_ _Cooperia curticei_ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken to a Leia o documento completo